A Retrospective Study on Adverse Events Following COVID–19 -Vaccines (AEFI) Reported to ADR Monitoring Centre in a Tertiary Care Health Centre, Andhra Pradesh
DOI:
https://doi.org/10.37506/cg97sh81Keywords:
AEFI, COVID-19 vaccines, Pharmacovigilance, COVISHIELD, COVAXIN.Abstract
Background – Vaccination against COVID-19 is going around globally to prevent the incidence of COVID-19 disease and its complications. As there have been no large-scale research studies about AEFI following COVID-19 vaccines, our plan of action was to examine and assess the clinical patterns that occur after COVID-19 immunization and determine which COVID-19 vaccine has a lower frequency of side effects.
Methods - This is a retrospective study of the AEFIs reported with COVID-19 vaccines (1st or 2nd dose or both) at the Government General Hospital, Guntur, AP, from Jan 16th, 2021 – October 31st 2021 after obtaining prior approval of the Institutional Ethics Committee (IEC) and PvPI, Ghaziabad. The ADR monitoring facility in Guntur collected and evaluated the adverse incidents reported using descriptive statistics in MS Excel. The results were presented in bar and pie charts.
Results – AMC received a total of 575 Adverse Events Following Immunization (AEFIs) after COVID-19 vaccinations were given. The most frequently detected adverse events following immunization (AEFIs) were fever, recorded in 21.9% (136 cases), headache in 20.9% (120 cases), nausea and vomiting in 4.3% (25 cases), and rashes in 2.1% (12 cases). The bulk of the Adverse Events Following Immunization (AEFIs) were moderate and occurred in individuals aged between 28 and 37 years. Adverse local responses were noted following the administration of the initial dosage of Covishield.
Conclusion: In this study, most of the negative events reported were non-serious. The incidence of adverse events following Covaxin was few compared to Covishield. The mean occurrence of symptoms was 0 to 4 days. Additionally, it is necessary to continue conducting longitudinal surveys in the field of pharmacovigilance to thoroughly examine any potential long-term negative effects of vaccines.
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